VIVUS has submitted a New Drug Application (NDA) to the FDA seeking approval of avanafil, its investigational drug for the treatment of erectile dysfunction (ED). The NDA submission follows the successful completion of an extensive phase III program for avanafil, which included over 1,350 patients, where avanafil was shown to be well tolerated and effective in treating men with ED.
"The efficacy was consistent across all patient groups, with success observed in some patients in as early as 15 minutes after dosing,” said Leland F. Wilson, CEO of VIVUS. “The drug was well tolerated and had a low dropout rate in all of the clinical trials. If approved, avanafil could be an attractive treatment alternative for the 30 million men in the United States who suffer from ED."
The NDA includes results from two placebo-controlled, randomized, double-blind, multicenter studies: REVIVE, which included 646 men from the general population with ED, and REVIVE-Diabetes, which included 390 diabetics. Also included are the results from the year-long safety study, TA-314, which included 712 continuation patients from the REVIVE and REVIVE-Diabetes studies.
The avanafil phase III program consists of three pivotal studies: TA-301 (REVIVE), TA-302 (REVIVE-Diabetes) and TA-303 (REVIVE-RP), as well as a 52-week, open-label, long-term safety study. TA-301, TA-302 and TA-303 were all randomized, double-blind, placebo-controlled studies of avanafil in patients with a history of ED for at least six months. Each of the trials has a similar design with patients undergoing a four-week, non-treatment run-in period followed by 12 weeks of treatment. Endpoints of the studies are improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the EF domain score of the International Index of Erectile Function (IIEF).